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Framework for Metals Risk Assessment
Federal Register Notices
Contact
- Lee Hofmann
- by phone at: 202-566-1928
- by email at: hofmann.lee@epa.gov
Notice
The Framework for Metals Risk Assessment, released on March 8, 2007, outlines key principles about metals and describes how they should be considered in conducting human health and ecological risk assessments. The Framework seeks to advance our understanding of the impact of metals in a consistent manner across the Agency's programs since inorganic metals and metal compounds present unique issues for risk assessors.
This guidance is not a prescriptive manual on how any particular type of assessment should be conducted within EPA, but rather it outlines the key principles when considering metals and offers advice on how these principles can be considered in metals assessments.The Framework serves as a single, comprehensive, state-of-the-science reference source from which the different programs within the Agency can evaluate their own methods and practices for assessing metals, and revise or update as appropriate. The Framework also provides a basis from which EPA programs can assess the hazards and risks of metals in a manner that is more consistent with the current state-of-the-science of metals and with each other.
External peer review of the Framework was conducted by EPA's Science Advisory Board (SAB) in February 2005, and their report to the Administrator (PDF) (95 pp, 600K) was finalized in January 2006.
Background
Given the complexity of issues surrounding metals risk assessment, the Framework took several years to develop. Originally, EPA's Risk Assessment Forum sought consultation from EPA's Science Advisory Board (SAB) on the science issues and principles that need to be addressed in the Framework document. EPA identified and commissioned scientific experts to write detailed papers on these issues: environmental chemistry, exposure, human health effects, ecological effects, bioavailability and bioaccumulation.
The draft Framework was then developed and relied heavily on these papers. To ensure broad input on the Framework, the Risk Assessment Forum engaged in extensive consultation with the scientific community, stakeholders, and intended users, including risk assessors in other federal agencies, in different regions, and in the states. Throughout the development process, the Agency has held stakeholder meetings and made the issue papers open for public comment.
History/Chronology
| Jan 2002 | EPA's Science Policy Council tasked an Agency workgroup, under the auspices of EPA's Risk Assessment Forum, with devising a Metals Action Plan (MAP) to establish a process for ensuring the consistent application of scientific principles to metals risk assessment. |
| Feb 2002 | EPA hosts a workshop to collect information for the development of a framework for metal risk assessment. |
| Sep 2002 | EPA's Science Advisory Board (SAB) reviewed the Agency's Draft Metals Action Plan, which called for the development of a framework for metals risk assessment. The SAB emphasized the importance of focusing on the unique properties of metals as they relate to environmental chemistry, bioavailability, bioaccumulation, exposure, and toxicity. |
| Dec 2002 | To inform the considerations of the unique properties of metals, and to engage the external scientific community, the Agency commissioned external experts to lead the development of a series of issue papers. |
| Sep 2003 | Draft issue papers were made available for public comment. [Public comments on the draft issue papers may be viewed at EPA's Docket by visiting http://www.regulations.gov and searching on Docket Number OAR-2003-0192.] |
| Jul 2004 | A peer consultation workshop was held on a draft Framework, followed by an interagency review. |
| Dec 2004 | Draft Issue Papers for Metals are made available for public comment. [Public comments on the draft Framework may be viewed at EPA's Docket by visiting http://www.regulations.gov and searching on Docket Number ORD-2004-0017.] Development of the Final Issue Papers for Metals were led by the ERG contractor and released in Oct 2004. |
| Feb 2005 | SAB held a peer review meeting on the draft Framework and conducted their external peer review. |
| Jan 2006 | SAB submitted their report to the Administrator (PDF) (95 pp, 600K). |
| Apr 2006 | Agency response (PDF) (6 pp, 534K) to the SAB on their peer review. |
| Feb 2007 | EPA's Response to Peer Review comments are addressed in the final report. |
| Mar 2007 | Release of final Framework for Metals Risk Assessment. |
Next Steps
This is the final report.
Downloads/Related Links
- Framework for Metals Risk Assessment (PDF) (171 pp, 895 KB, about PDF)
- Metals Framework Fact Sheet
Related Link(s)
Citation
U.S. EPA. Framework for Metals Risk Assessment. U.S. Environmental Protection Agency, Washington, D.C., EPA/120/R-07/001.
